A study of MRgFUS treatment for painful bone metastases

Not Applicable

• Conditions: metastatic bone tumor

• Registration Number: JPRN-jRCTs032180439
• Lead Sponsor: Kawano Hirotaka

Brief Summary

This study was started in November 2017, but very few patients met the eligibility criteria.Before the study, we had planned to evaluate the changes of the NRS score, but we failed to continue the study, because we could not obtain an enough case to achieve any reliable results. Although a statistically significant difference could not be obtained, MRgFUS may be effective in pain relief seeing the NRS scores at the end of observation were lower.There were no adverse events.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-27
• Study Completion: 2019-07-18
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

1) Patients who are suffuring from symptoms of bone metastases and are not suitable to other accepted available treatments, such as surgery, radiation and chemotherapy, or refuse other altanitive therapy.
2) Patients with persistent distinguishable pain associated with 1 site to be treated (if patient has pain from additional sites, the pain from the additional sites must be evaluated as being less intense by at least 2points on the NRS compared to the site to be treated.)
3) Targeted tumor size under 8cm in diameter.
4) Patient whose targeted tumor is on bone and is deeper than 10-mm from the skin.
5) Targeted tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible.
6) Able to communicate sensations during the ExAblate treatment.
7) Patients who are able and willing to give consent and able to attend all study visit.

Exclusion Criteria

1) Patients with uncontrolled pain lesion except for targeted tumor.
2) More than 4 painful lesions.
3) Patients with NRS (0-10 scale) pain score <4 irrespective of medication.
4) No radiation therapy or chemotherapy in the past two weeks.
5) Patients with unstability of targeted tumor:
-Pathological fracture
-Need surgical stabilization in impending fracture.
-Patients with surgical stabilization with metallic hard ware.
6) Patients on dialysis.
7) Patients with unstable cardiac status which interfere with daily life.
-Unstable angina pectoris on medication.
-Patients developed myocardial infarction within six months of protocol entry.
-Congestive heart failure requiring medication (other than siuretic).
-Any patients disqualified by a study physician because of their cardiac status.
8) Patients with severe hypertension (diastolic BP > 100 on medication).
9) Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices including cardiac pacemakers, size limitations (weight > 113kilograms) and claustrophobia.
10) Known hypersensitivity to the MRI contrast agent (e.g. Magnevist etc.) including advanced kidney disease.
11) Karnofsky Performance Status < 60.
12) Severe cerebrovascular disease (multiple CVA or CVA within 6 months).
13) Individuals who are not able to tolerate prolonged stationary position during treatment (approximately 2 hrs).
14) Patients whose targeted tumor is less than 10-mm from nurve bundle, intestine or bladder.
15) Patients who are participating or have participated in another clinical trial in last 30 days.
16) Patients unable to communicate with the investigator and staff.
17) Pain source unidentifiable.
18) Patients who are pregnant or lactating.
19) Conspicuous prolong of coagulation time (limit to INR>1.5).
20) Any patients disqualified by a study physician or any other reason.

Study & Design

• Study Type: Interventional
• Study Design: Not specified